Background: There are limited data of immunologic and virologic failure in Asian HIV-infected children using nonnucleoside\r\nreverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral therapy (HAART). We examined\r\nthe incidence rate of immunologic failure (IF) and virologic failure (VF) and the accuracy of using IF to predict VF in\r\nThai HIV-infected children using first-line NNRTI-based HAART.\r\nMethods: Antiretroviral (ART)-na�¯ve HIV-infected children from 2 prospective cohorts treated with NNRTI-based\r\nHAART during 2001-2008 were included. CD4 counts were performed every 12 weeks and plasma HIV-RNA\r\nmeasured every 24 weeks. Immune recovery was defined as CD4%=25%. IF was defined as persistent decline of\r\n=5% in CD4% in children with CD4%<15% at baseline or decrease in CD4 count =30% from baseline. VF was\r\ndefined as HIV-RNA>1,000 copies/ml after at least 24 weeks of HAART. Clinical and laboratory parameter changes\r\nwere assessed using a paired t-test, and a time to event approach was used to assess predictors of VF. Sensitivity\r\nand specificity of IF were calculated against VF.\r\nResults: 107 ART-naive HIV-infected children were included, 52% female, % CDC clinical classification N:A:B:C\r\n4:44:30:22%. Baseline data were median (IQR) age 6.2 (4.2-8.9) years, CD4% 7 (3-15), HIV-RNA 5.0 (4.9-5.5)\r\nlog10copies/ml. Nevirapine (NVP) and efavirenz (EFV)-based HAART were started in 70% and 30%, respectively.\r\nAt 96 weeks, none had progressed to a CDC clinical classification of AIDS and one had died from pneumonia.\r\nOverall, significant improvement of weight for age z-score (p = 0.014), height for age z-score, hemoglobin, and\r\nCD4 were seen (all p < 0.001). The median (IQR) CD4% at 96 weeks was 25 (18-30)%. Eighty-nine percent of\r\nchildren had immune recovery (CD4%=25%) and 75% of children had HIV-RNA <1.7log10copies/ml.\r\nThirty five (32.7%) children experienced VF within 96 weeks. Of these, 24 (68.6%) and 31 (88.6%) children had VF in\r\nthe first 24 and 48 weeks respectively.\r\nOnly 1 (0.9%) child experienced IF within 96 weeks and the sensitivity (95%CI) of IF to VF was 4 (0.1-20.4)% and\r\nspecificity was 100 (93.9-100)%.\r\nConclusion: Immunologic failure, as defined here, had low sensitivity compared to VF and should not be\r\nrecommended to detect treatment failure. Plasma HIV-RNA should be performed twice, at weeks 24 and 48, to\r\ndetect early treatment failure.
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